Contact lenses having a reinforcing scaffold

ABSTRACT

Ophthalmic lenses for correcting refractive error of an eye are disclosed. Ophthalmic lenses include an inner optic portion having a scaffold between an anterior portion and a posterior portion. The scaffold is characterized by a substantially uniform thickness formed from a material characterized by a modulus that his higher than the modulus of the peripheral portion. Openings within the scaffold are filled with a low modulus material. When applied to an eye, the lenses are configured to provide one or more lenticular volumes between the posterior surface of the lens and the cornea. The disclosure further relates to methods of correcting refractive errors of an eye such as astigmatism or spherical aberration using the ophthalmic lenses.

This application is a Continuation of U.S. application Ser. No.14/539,698, filed on Nov. 12, 2014, which claims benefit under 35 U.S.C.§119(e) of U.S. Provisional Application No. 61/904,992, filed on Nov.15, 2013, which is incorporated by reference in its entirety.

FIELD

This disclosure relates to ophthalmic lenses for correcting refractiveerror of an eye. Ophthalmic lenses include an inner optic portion havinga scaffold between an anterior portion and a posterior portion. Thescaffold is characterized by a substantially uniform thickness formedfrom a material characterized by a modulus that is higher than themodulus of the peripheral portion. Openings within the scaffold arefilled with a low modulus material. When applied to an eye, the lensesare configured to provide one or more lenticular volumes between theposterior surface of the lens and the cornea. The disclosure furtherrelates to methods of correcting refractive errors of an eye such asastigmatism or spherical aberration using the ophthalmic lenses.

BACKGROUND

Hybrid or bimodular contact lenses, lenses having a comparatively rigidcentral portion and a soft skirt or peripheral portion are used tocorrect refractive error of the eye such as astigmatism. Currentproducts such as rigid gas permeable (RGP) and soft toric lenses forcorrecting refractive error include a cylindrical component in additionto any spherical corrective component that must be determined for eachpatient and oriented with respect to the optical region of the cornea tomaintain optimal vision correction. Features are incorporated into thelens to maintain centration and radial orientation of the lens of theeye during wear. Because of the need to fit and orient the cylindricalcorrective component, a large number of lenses must be maintained ininventory and individually fit and selected for each patient.

In light of the above, it is desirable to provide improved contactlenses for vision correction. Ideally, these contact lenses wouldprovide treatments that improve tear flow and avoid at least some of thedeficiencies of known techniques while providing improved patientcomfort and/or vision. It is also desirable to provide improved contactlenses for correcting refractive error that only require a spherical fitand provide comfort and vision correction as good as or better thancurrent toric lens products.

BRIEF SUMMARY

In a first aspect, ophthalmic lenses for correcting a refractive errorof an eye are provided, the ophthalmic lenses comprising an inner opticportion configured to be disposed over an optical region of the corneaand comprising a center portion configured so that a posterior surfaceof the inner optic portion is characterized by a shape diverging from arefractive shape of the cornea, wherein the center portion comprises ascaffold; and a peripheral portion disposed radially outward of theinner optic portion.

In a second aspect, methods for correcting a refractive error of an eyeare provided, the eye having a cornea with a refractive shape extendingacross an optical region of the cornea, the method comprisingpositioning an ophthalmic lens on the cornea so that an inner opticportion of the ophthalmic lens is disposed over the optical region ofthe cornea, wherein the ophthalmic lens comprises: an inner opticportion configured to be disposed over the optical region of the corneaand comprising a center portion configured so that a posterior surfaceof the inner optic portion has a shape diverging from the refractiveshape of the cornea, wherein the center portion comprises a scaffold;and a peripheral portion disposed radially outward of the inner opticportion.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1D show top, side, perspective and cross-section views of anophthalmic lens according to certain embodiments.

FIGS. 2A-2D show top, side, perspective and cross-section views of ascaffold according to certain embodiments.

FIGS. 3A-3D show top, side, perspective and cross-section views of ascaffold according to certain embodiments.

FIGS. 4A-4D show top, side, perspective and cross-section views of ascaffold according to certain embodiments.

FIGS. 5A-5D show top, side, perspective and cross-section views of ascaffold according to certain embodiments.

FIGS. 6A-6D show top, side, perspective and cross-section views of ascaffold according to certain embodiments.

Reference is now made in detail to embodiments provided by the presentdisclosure. The disclosed embodiments are not intended to be limiting ofthe claims.

DETAILED DESCRIPTION

As used herein, mathematical equations and scientific notation can beused to identify values in many ways understood by a person of ordinaryskill in the art. As used herein the symbol “E” can be used to expressan exponent in base 10, such that 1E1 equals 10, 2E1 equals 20, and 4E2equals 400. Units can be expressed in many ways and as would beunderstood by a person of ordinary skill in the art, for example “m” asmeters, “Pa” as the Pascal unit for pressure, “MPa” as Mega Pascal.

As used herein, an on K fit of a device such as a contact lensencompasses fitting the contact lens to the flattest meridian of thecornea and the on K fit can be flatter than the flattest meridian withinabout 1.5 D. For example, for a cornea having keratometer values (Kvalues) of about 44 D axis 90 and 43 D axis 180, the on K fit wouldprovide a device having a curvature corresponding to an optical powerwithin a range from about 43 D to about 41.5 D for the region of the eyemeasured. The on K fit as described herein can allow for tear liquid toform under the device such that the tear liquid can be pumped inaccordance with embodiments as described herein.

The optical power of the cornea in Diopters (D) can be related to theradius R of curvature of the cornea with the formula D=(1.3375−1)/R,where 1.3375 corresponds to the index of refraction of the tear fluid.The curvature of the cornea is inversely related to the radius ofcurvature R such that as the radius of curvature increases the curvatureof the cornea decreases and such that as the radius of curvaturedecreases, the curvature of the cornea increases.

Dk refers to oxygen permeability, i.e., the amount of oxygen passingthrough a device such as a contact lens over a given period of time andpressure difference conditions. Dk is express in units of 10⁻¹¹(cm/sec)(mL O₂)(mL×mm Hg), also known as a barrer. Oxygentransmissibility can be expressed as Dk/t, where t is the thickness ofthe structure such as a contact lens and therefore Dk/t represents theamount of oxygen passing through a contact lens of a specified thicknessover a given set of time and pressure difference conditions. Oxygentransmissibility has the units of barrers/cm or 10⁻⁹ (cm/sec)(mLO₂)(mL×mm Hg).

The terms outer portion of a lens and peripheral portion of a lens areused interchangeably. The outer or peripheral portion is disposedradially around and connected to the inner portion of a covering orcontact lens. In general, the outer or peripheral portion tapers from athickness at the interface with the inner portion toward the outer orperipheral edge of the covering or contact lens. The outer or peripheralportion may be further characterized by sub-portions characterized by,for example, different radii of curvature, thickness, rigidity, andmaterial. The sub-portions may be configured radially around the centeroptic portion. Furthermore, the outer or peripheral portion is typicallydisposed outside the optical region of the cornea with the covering orcontact lens centered on the cornea of an eye. The inner portionincludes a central inner optic portion through which the eye sees. Theinner portion may have a diameter that is larger than the diameter ofthe inner optic portion The inner portion is also referred to herein asthe inner or optical component or button. The outer portion is alsoreferred to herein as the outer or coupling component.

The posterior surface of a contact lens or portion refers to a surfacethat is near to or faces the cornea during wear by a patient. Theanterior surface of a contact lens or portion refers to a surface thatis away from or faces away from the cornea during wear by a patient.

Bimodulus contact lenses having an inner optic portion with a materialhaving a higher modulus than the material forming the outer peripheralportion can provide refractive correction independent of the sphericalorientation on the cornea. The modulus of a material forming the inneroptic portion provides a sufficiently rigid structure to provide aspherical posterior lens surface. Any non-spherical portions of thecornea are effectively spanned by the posterior lens surface to definelenticular volumes between the posterior lens surface and the cornea.When filled with tear fluid, the lenticular volumes form a tear lens.Because a bimodulus lens is spherically symmetric, astigmatic error canbe corrected regardless of the spherical orientation on the cornea,eliminating the need for alignment or orientation features.

To provide sufficient rigidity of the inner optic portion, the materialforming the inner optic portion can be relatively thin and becharacterized by a high modulus, or can be relatively thick and becharacterized by a lower modulus. Lower modulus materials and thincontact lenses generally enhance comfort of contact lens wear. Toenhance comfort, a high modulus material may be covered with layers oflow modulus material. This approach has the advantage that the highmodulus material can be retained by and disposed within a low modulusmaterial.

Eye health is promoted by oxygen permeability. For contact lenses, it isgenerally desirable that the oxygen permeability be greater than about80 Dk. This high oxygen permeability can be difficult to obtain for highmodulus materials and/or for thicker material cross-sections.

To provide spherically symmetric contact lenses capable of correctingastigmatic error, contact lenses are disclosed in which the inner opticportion includes a center portion having a scaffold formed from a highmodulus material and characterized by a substantially uniform thickness.

The scaffold of the center portion imparts sufficient rigidity to thecenter optic portion to provide a spherical anterior lens surface and aspherical posterior lens surface for correcting refractive error.

FIGS. 1A-1D show various views of a contact lens having a scaffold. FIG.1D shows a cross-section of a contact lens having an inner optic portion101, peripheral portion 102, anterior surface 103, and posterior surface104. Inner optic portion 101 includes anterior portion 105, centerportion 106, and posterior portion 107. Center portion 106 ischaracterized by a substantially uniform thickness and is embeddedbetween anterior portion 105 and posterior portion 107. As suggested byFIG. 1D, anterior portion 105, posterior portion 107, and peripheralportion 102 may be formed from the same material, and center portion 106may be formed from a different material. In certain embodiments, centerportion 106 also includes openings, which are not shown in FIG. 1D. Theanterior surface 103 and the posterior surface 104 of the inner opticportion are characterized by a spherically symmetric profile. A centerportion may have the same diameter as the inner portion, may have adiameter greater than that of the inner portion, or may have a diametersmaller than that of the inner portion. The inner portion may have adiameter that is larger than the inner optic portion through which theeye sees.

In certain embodiments, the center portion is a solid material and ischaracterized by a substantially uniform thickness. In certainembodiments, the solid material is homogenous.

In certain embodiments, the center portion may be configured withopenings, holes, channels or other features such that the center portionserves as a scaffold or structural support rather than as a continuoussection or button of homogeneous material.

The openings can serve several functions including, for example,increasing oxygen permeability, increasing tear flow, and enabling theuse of a high modulus material in the inner portion while maintaining arelatively thin cross-sectional profile. Furthermore, the openings canbe filled with another optical material such as a low modulus materialthat can serve to retain and thereby increase the mechanical integrityof the bimodulus contact lens.

The openings in the center portion may be any suitable configuration.Examples of suitable configurations are shown in FIGS. 2A-6D. Ingeneral, the configuration of the openings is selected to provide asuitable rigidity to the center optic portion, to enhance vision, and topromote eye health.

FIGS. 2A-2D show a scaffold configuration in which round openings havingsimilar diameters are disposed throughout the center portion. The roundopenings may be disposed in any suitable configuration and may form aregular or irregular pattern. Each of the round openings may havesimilar diameters, may have different diameters, or may have acombination of diameters. Round openings having different diameters maybe disposed in certain regions of the center portion. For example, theround openings toward the central axis may have a larger diameter thanthose located toward the outer edge of the center portion. In certainembodiments, the openings are disposed to minimize any opticaldistortion to normal vision and to optimize visual acuity. Thecross-sectional profile of any opening may have any suitable shape suchas oval and are not necessarily round.

In certain embodiments, the round openings may have a diameter rangingfrom 10 μm to 1000 μm including, for example, 50 μm to 500 μm, 100 μm to500 μm, or 50 μm to 250 μm. In certain embodiments, the openings mayhave at least one dimension ranging from 10 μm to 1000 μm including, forexample, 50 μm to 500 μm, 100 μm to 500 μm, or 50 μm to 250 μm.

FIGS. 3A-3D show a scaffold configuration in which the center portionincludes a large-diameter opening located in the center with smalleropenings disposed toward the outer edge of the scaffold. In suchembodiments, the center opening may have a diameter from 1 mm to 4 mm orother suitable diameter.

FIGS. 4A-4D show a scaffold having a plurality of smaller openingslocated along circles centered around the center axis of the scaffold.Notably, FIG. 4C also shows that the openings are angled with respect tothe cross-sectional thickness of the scaffold. Thus, in certainembodiments, the openings may be substantially perpendicular to thecross-sectional thickness of the scaffold, and in certain embodiments,may be angled with respect to the cross-sectional thickness of thescaffold.

FIGS. 5A-5D show a scaffold configuration in which the center portionhas wedge-shaped openings forming a hub-and-spoke arrangement. As shownin FIGS. 5A-5D, the center portion includes ten wedge-shaped openings.However, any suitable number of wedge-shaped openings may be employed.For example, FIGS. 6A-6D show a configuration in which the centerportion includes four wedge-shaped openings.

It can be appreciated that other configurations of openings arepossible. In certain embodiments it may be desirable that openings berelatively large to facilitate manufacture and/or to minimize theinterface area between the scaffold and the material in which thescaffold is embedded.

In certain embodiments, openings can be in the form of concentric ringsheld together by ribs. In other embodiments, a scaffold may include acentral opening with structural support provided concentric to the opticaxis of the scaffold. In such configurations, the scaffold can take theform of a concentric ring or modified concentric ring disposed outsidethe inner optic portion of the lens. In general, the number, dimensions,and configuration of the openings in the scaffold can be selected toprovide a desired rigidity and minimize interference with normal visionand optimize visual acuity. Manufacturing and reliability can also beimportant to the selection of appropriate scaffold designs.

The number, size, and/or shape of the openings may be selected toprovide sufficient rigidity and oxygen permeability to the inner opticportion of the ophthalmic lens. The number, size, and/or shape of theopenings may also be selected to facilitate manufacturing. For example,depending on whether the center portion is fabricated using injectionmolding, compression molding, cast molding, or other suitable moldingtechnology, the design may be selected to facilitate themanufacturability and quality of the part.

The openings in the center portion may be distinguished from openingsused to enhance tear flow and oxygen permeability. Such openings thatextend through the thickness of a contact lens are generallycharacterized by a diameter less than 100 μm. In contrast, the openingsused to provide high modulus scaffolds of the present disclosure arelarger such that, in certain embodiments, the scaffold itself is only asmall portion of the inner optic portion.

The center scaffold is primarily configured to provide mechanicalstructure. In certain embodiments, the center scaffold is not configuredto provide an optical function.

In certain embodiments, the center scaffold section is characterized bya substantially uniform thickness. A substantially uniform thicknessrefers to a thickness that varies less than +/−2% across the profile,+/−5% across the profile, and in certain embodiments less than +/−10%across the profile, where percent is based on the nominal thickness ofthe scaffold. In certain embodiments, the center scaffold portion may becharacterized by a non-uniform thickness; however, the effect of thenon-uniform thickness is not to affect the optical properties of theinner optic portion. For example, the center scaffold portion may bethicker toward the edge or may be thicker toward the center. However,the optical properties of contact lenses provided by the presentdisclosure are determined by the spherically-shaped anterior andposterior lens surfaces.

In certain embodiments, the anterior portion is characterized by athickness from about 25 μm to about 250 μm, the posterior portion ischaracterized by a thickness from about 25 μm to about 250 μm, and incertain embodiments, both the anterior portion and the posterior portionare characterized by a thickness from about 25 μm to about 250 μm.

In certain embodiments, the scaffold can be characterized by a thicknessfrom about 50 μm to about 300 μm, from about 75 μm to about 300 μm, fromabout 100 μm to about 275 μm, from about 125 μm to about 250 μm, and incertain embodiments, from about 125 μm to about 225 μm.

In certain embodiments, a scaffold is characterized by a curvatureconfigured to fit within a smooth cross-section profile of the contactlens. The scaffold may have a diameter smaller than the optical regionof the cornea, larger than the optical region of the cornea, or aboutthe same diameter as the optical region of the cornea.

In general, the thickness, diameter, curvature, and design of thescaffold are configured to maintain a spherically symmetric posteriorsurface of the lens. The lens may deform upon blinking but maysufficiently recover so as not to significantly affect vision of theeye.

In certain embodiments, the maximum thickness of the inner optic portionis from about 100 μm to about 500 μm, in certain embodiments, from about150 μm to about 350 μm, from about 200 μm to about 300 μm, and incertain embodiments, from about 225 μm to about 275 μm.

In certain embodiments, the anterior portion, the posterior portionand/or the filler material is characterized by an oxygen permeabilityfrom about 10 Dk to about 500 Dk, from about 50 Dk to about 400 Dk, fromabout 50 Dk to about 300 DK, and in certain embodiments from about 50 DKto about 100 Dk.

In certain embodiments, the material forming the scaffold ischaracterized by an oxygen permeability from about 0 Dk to about 300 Dk,from about 0 Dk to about 100 DK, and in certain embodiments, from about0 Dk to about 50 Dk.

In certain embodiments, the high modulus scaffold represents from about20 vol % to about 80 vol % of the center portion, from about 30 vol % toabout 70 vol %, from about 30 vol % to about 60 vol %, and in certainembodiments, from about 30 vol % to about 50 vol % of the total volumeof the center portion.

In certain embodiments, the modulus of the material forming the scaffoldranges from 300 MPa to 3000 MPa, from 500 MPa to 2000 MPa, from 800 MPato 1800 MPa, and in certain embodiments from 1000 MPa to 1400 MPa.

In certain embodiments, a center portion is characterized by a rigidityfrom about 1E9 MPa-μm³ to 1E11 MPa-μm³, from 1E9 to 5E10 MPa-μm³, from1E9 MPa-μm³ to 2E10, from 2E9 to 2E10 MPa-μm³, from 4E9 MPa-μm³ to 2E10MPa-μm³, from 6E9 MPa-μm³ to 2E10 MPa-μm³, and in certain embodiments,from 8E9 MPa-μm³ to 2E10 M Pa-μm³.

In certain embodiments, the contact lens is configured to have a maximumthickness less than about 400 μm and an inner optic portioncharacterized by a rigidity from about 1E9 MPa-μm³ to about 1E11MPa-μm³.

In certain embodiments, the contact lens is configured to have a maximumthickness less than about 350 μm and an inner optic portioncharacterized by a rigidity from about 1E9 MPa-μm³ to about 5E10MPa-μm³.

In certain embodiments, the contact lens is configured to have a maximumthickness less than about 300 μm and an inner optic portioncharacterized by a rigidity from about 1E9 MPa-μm³ to about 2E10MPa-μm³.

The high modulus material is formed into a disc-like part or scaffoldthat can be embedded in a soft material. The part made from the highmodulus material can be of substantially uniform thickness across itsdiameter, meaning it has no optical power by itself. The anterior andposterior surfaces of the inner optic portion can be made from the lowmodulus material and dictate the optics of the system. The scaffold maybe a continuous structure with smooth surfaces or it may be modifiedwith uniform through holes, non-uniform through holes, a spoke-likepattern, an open-cell foam, or other pattern that permits gas flow whilemaintaining structural integrity. The material may be removed such thatthe through holes are oriented normal to the surface of the scaffold ordiagonally oriented at any angle. The open space created by removingmaterial from the scaffold can be filled with a low modulus material.This will allow for the use of low oxygen permeable materials as thehigh modulus material. The lower the oxygen permeability of the rigidmaterial, the more material can be removed in order to create a partwith sufficient oxygen permeability. As more material is removed fromthe scaffold, its ability to reinforce the optical shape formed by thesoft material can decrease. Therefore, a balance can be made in materialmodulus and oxygen permeability to design an oxygen permeablereinforcing structure made from the high modulus material. Oxygentransmissibility of an inner optic portion having a rigid scaffold andlow modulus anterior, posterior and filling portions can be estimatedusing the Equation (1) and Equation (2):

$\begin{matrix}{\frac{Dk}{t} = {100*\left( {\frac{s_{b}}{\left( {\frac{t_{a}}{{Dk}_{a}} + \frac{t_{b}}{{Dk}_{b}} + \frac{t_{d}}{{Dk}_{d}}} \right)} + \frac{s_{c}}{\left( {\frac{t_{a}}{{Dk}_{a}} + \frac{t_{c}}{{Dk}_{c}} + \frac{t_{d}}{{Dk}_{d}}} \right)}} \right)}} & (1) \\{{Rigidity} = {t_{t}^{3}\left( {{E_{a}*f_{a}} + {s_{a}*E_{b}*f_{b}} + {s_{c}*{Ec}*f_{c}} + {E_{d}*f_{d}}} \right)}} & (2)\end{matrix}$Dk_(x)=Oxygen Permeability of material “x” (Fatt Units)t_(x)=thickness of material “x” (microns) (t_(t)=total thickness ofsystem)f_(x)=t_(x)/t_(t)s_(x)=fractional amount of material “x” that exists across thickness t,(for an un-modified disc: s_(x)=1)E_(x)=Young's Modulus of Material “x.”The results of example calculations are shown in Table 1.

In general, low modulus materials are characterized by high oxygenpermeability such as oxygen permeability from about 10 Dk to about 500Dk, and in certain embodiments from about 100 Dk to 400 Dk.

In general, high modulus materials are characterized by low oxygenpermeability such as less than 300 Dk, less than 200 Dk, less than 100Dk, less than 50 Dk, and in certain embodiments, less than 10 Dk.

In general, for a continuous wear contact lens it is desirable that theoxygen transmissibility be at least 50 Dk/t, at least 80 Dk/t, at least90 Dk/t, and in certain embodiments, at least 100 Dk/t.

To reduce optical artifacts it is desirable that the refractive index ofthe material forming the scaffold be closely matched to the refractiveindex of the material filling the openings and forming the anteriorportion and the posterior portion of the inner optic portion. Forexample, in certain embodiments, the difference in the refractive indexis less than 0.03, less than 0.025, less than 0.02, less than 0.015,less than 0.010 and in certain embodiments, less than 0.005.

The material forming the scaffold and the material forming the anteriorportion, posterior portion, and the filler portion should have similarindices of refraction in order to minimize internal reflections withinthe part. For example, a Boston EO RGP has a refractive index of 1.429(Modulus=1600 MPa) can be used with a soft material, for examplelotrafilcon A that has a refractive index of 1.43. If using the BostonEqualens II (refractive index=1.423) a soft material such as hefilcon B(refractive index 1.42) can be used.

The materials forming the scaffold and the materials filling theopenings in the scaffold, the anterior portion, and the posteriorportion of the inner optic portion of the contact lens can be selectedto have similar chemistries such that covalent bonds form between thedissimilar materials. For example, the low modulus material and the highmodulus material forming the scaffold may be silicon-based or maycontain silicon. Thus, in certain embodiments, the scaffold may beformed from a blend of silicon and other material.

Alternatively, to ensure adhesion between the scaffold and the surroundmaterial the surface of the scaffold may be treated to enhance adhesionsuch as plasma treatment or other suitable treatment method.

Contact lenses formed from dissimilar hydrous material can be difficultto manufacture because of differential swelling of the materials duringhydration. Therefore, it is desirable to select the low modulus and highmodulus materials to exhibit similar swelling when hydrated.Alternatively, to avoid or at least minimize problems associated withdifferential swelling, the low modulus materials and the high modulusmaterials can be selected to be non-hydrous such that the materialsexhibit minimal swelling when hydrated.

Eye health is promoted by the presence and flow of tear fluid along thesurface of the cornea. Because the contact lenses provided by thepresent disclosure are spherically symmetric and are configured tocorrect astigmatic error independent of the orientation on the cornea,the lenses can freely move and thereby promote the flow and exchange oftear fluid across the surface of the cornea. The scaffold can furtherhelp to center the contact lens on the cornea following blinking.Alternatively, or in addition to, fenestrations may be provided throughthe contact lens proximate to the inner optic region and/or in theperipheral region to further promote the flow and exchange of tearfluid. The fenestrations may further serve to maintain a reservoir oftear fluid within the lenticular volume and thereby support thespherical profile of the posterior surface of the contact lens.

The base curve and the spherical power of the lens can be independent ofthe shape of the scaffold.

The material forming the center scaffold portion is characterized by arefractive index similar to that of the other materials forming theinner optic portion of the contact lens. In certain embodiments, thematerial forming the center scaffold portion is characterized by arefractive index that is similar to that of the cornea such as, forexample, from about 1.4 to about 1.5, from about 1.42 to about 1.48, andin certain embodiments, from about 1.43 to about 1.47.

The openings in the center scaffold portion are filled with aninterstitial material. The interstitial material will generally becharacterized by a lower modulus and a higher oxygen permeability thanthe modulus and oxygen permeability of the center scaffold material. Inaddition, the material filling the openings in the scaffold will have arefractive index that is substantially similar to the material formingthe scaffold. For example, in certain embodiments the material fillingthe openings in the scaffold will be characterized by a refractive indexfrom about 1.4 to about 1.6.

In addition to the center scaffold portion, the inner optic portionincludes at least one layer of material anterior to the center scaffoldportion, and at least one layer of material posterior to the centerscaffold portion. The materials located anterior and posterior to thecenter scaffold portion may be the same or may be different materials.For ease of fabrication, in certain embodiments, the materials locatedanterior and posterior to the center scaffold portion can be the samematerials.

In certain embodiments, the material filling the openings in thescaffold will be the same as the material forming the anterior and/orposterior materials of the inner optic portion.

In certain embodiments, the material forming the anterior and/orposterior materials of the inner optic portion will extend to theperipheral portion and in certain embodiments will be the same materialas the peripheral portion.

Material forming the anterior and/or posterior portions of the inneroptic portion may be characterized by a modulus from 0.1 MPA to 10 MPa,from 0.1 MPa to 5 MPa, or in certain embodiments from 0.1 to 2 MPa. Incertain embodiments, the filler material in the scaffold openings may becharacterized by a modulus from 0.1 MPA to 10 MPa, from 0.1 MPa to 5MPa, or in certain embodiments from 0.1 to 2 MPa.

In certain embodiments, the material forming the anterior and/orposterior portions of the inner optic portion may be formed from amaterial characterized by a high oxygen permeability (Dk, cm·mLO₂/sec·mL·mm Hg) such as from 100×10⁻¹¹ to 500×10⁻¹¹, from 200×10⁻¹¹ to500×10⁻¹¹, from 250×10⁻¹¹ to 450×10⁻¹¹, from 300×10⁻¹¹ to 400×10⁻¹¹, andin certain embodiments, about 350.

In certain embodiments, devices provided by the present disclosure arecharacterized by a high oxygen transmissibility (Dk/t) such as at leastabout 50×10⁻⁹, at least about 80×10⁻⁹, at least about 100×10⁻⁹, and incertain embodiments, at least about 120×10⁻⁹.

The material forming the anterior portion, posterior portion, and/orfiller portion of the inner optic portion may be hydrous or in certainembodiments may be anhydrous. An anhydrous material refers to a materialhaving a water content, when fully hydrated, less than 10 wt %, lessthan 5 wt %, and in certain embodiments, less than 2 wt %. A hydrousmaterial refers to a material having a water content, when fullyhydrated, greater than 10 wt %.

In certain embodiments, a lens may comprise silicone or siliconehydrogel having a low ionoporosity. For example, a device may comprisesilicone hydrogel or silicone comprising a low ion permeability, and therange of water can be from about 5% to about 35%, such that the Dk is100×10⁻¹¹ or more. In certain embodiments, the low ion permeability maycomprise an Ionoton Ion Permeability Coefficient of no more than about0.25×10⁻³ cm²/sec, for example no more than about 0.08×10⁻³ cm²/sec.

An ophthalmic lens may comprise a wettable surface coating disposed onat least the upper side (anterior surface) of the device, such that thetear film of the patient is smooth over the device and the patient cansee. The wettable surface coating may comprise a lubricious coating forpatient comfort, for example to lubricate the eye when the patientblinks. The wettable coating may create a contact angle no more thanabout 80 degrees. For example the coating may create a contact angle nomore than about 70 degrees, and the contact angle can be within a rangefrom about 55 degrees to 65 degrees to provide a surface with a smoothtear layer for vision. For example, the wettable coating can be disposedboth an upper surface and a lower surface of the device, i.e., on theanterior and posterior surface of the ophthalmic lens. The upper surfacemay comprise the wettable coating extending over at least the inneroptic portion.

A wettable coating may comprise one or more suitable materials. Forexample, the wettable coating may comprise polyethylene glycol (PEG),and the PEG coating can be disposed on Parylene™. Alternatively, thewettable coating 134 may comprise a plasma coating, and the plasmacoating may comprise a luminous chemical vapor deposition (LCVD) film.For example, the plasma coating may comprise at least one of ahydrocarbon, for example, CH₄, O₂ or fluorine containing hydrocarbon,for example, CF₄ coating. Alternatively or in combination, a wettablecoating may comprise a polyethylene glycol (PEG) coating or2-hydroxyethylmethacrylate (HEMA). For example, awettable coating maycomprise HEMA disposed on a Parylene™ coating, or a wettable coating maycomprise N-vinylpyrrolidone (NVP) disposed on a Parylene™ coating.

In certain embodiments, ophthalmic lenses provided by the presentdisclosure are configured to correct refractive error such asastigmatism. The lenses provide a smooth spherical anterior surface andminimize lens-induced distortions by reducing flexure of the inneroptical portion and by maintaining lens centration during wear. Reducedflexure of the inner optical portion can in part be accomplished byincreasing the rigidity of the inner portion and by creating a tearlens. Centration of the inner optical portion minimizes astigmatic andprismatic effects caused by tilting of the optic and also minimizes edgedistortion.

Ophthalmic lenses provided by the present disclosure can achieve visualcorrection at least equivalent to that of soft toric contact lenses andachieve a superior comfort level compared to soft toric contact lenses.Furthermore, because the ophthalmic lenses provided by the presentdisclosure are radially symmetric, fitting to an eye of the patientinvolves only accommodating the spherical correction and an inventory oflenses for correcting cylindrical error is not required.

Ophthalmic lenses provided by the present disclosure include an inneroptic portion configured to be disposed over the optical region of thecornea and a peripheral or outer portion that is disposed radiallyoutward of the inner portion. An ophthalmic lens includes a posteriorsurface that extends along the inner portion of the lens and is adjacentan eye when applied to an eye of a patient. An ophthalmic lens alsoincludes an anterior surface that extends along the outer surface of thelens and opposite the posterior surface. In general, the inner portionof a lens is configured to improve vision and the peripheral portion isconfigured to improve comfort. However, the configuration of the innerportion can also play a role in determining patient comfort, and theperipheral portion, at least in part, by maintaining centration of theinner optical portion on the optical portion of the cornea during wearenhances the visual outcome.

The inner optical portion of a lens is configured so that engagement ofthe posterior surface against the eye deforms the posterior surface sothat the posterior surface of the inner portion has a shape divergingfrom the refractive shape of the epithelium and optical portion of thecornea. The anterior surface of the inner portion of the ophthalmic lensprovides a spherical surface to correct a patient's vision.

In certain embodiments, the inner optical portion of a lens ischaracterized by a diameter from about 5 mm to about 10 mm, from about 7mm to about 9 mm, from about 7.5 mm to about 8.5 mm, from about 7.8 mmto about 8.2 mm, and in certain embodiments, about 8 mm. The anteriorinner portion of a lens is characterized by a substantially sphericalprofile without a cylindrical component.

In certain embodiments, the material forming a device including both theinner and outer portions have low water content and is characterized bylow water or ion permeability. In certain embodiments, the water contentis less than about 5%, less than about 4%, and in certain embodiments,less than about 3%. In certain embodiments, the material forming adevice has a water content less than about 1%, less than about 0.6%, andin certain embodiments, less than about 0.3%. In certain embodiments,the material less than about 0.4×10⁻⁶ cm²/sec, less than about 0.2×10⁻⁶cm²/sec, and in certain embodiments, less than about 0.1×10⁻⁶ cm²/sec.

A peripheral portion is disposed radially outward of the inner portionof an ophthalmic lens. In general, the peripheral portion retains theinner portion and is characterized by approximately the same thicknessas the inner portion at the interface between the inner and peripheralportions, and the thickness of the peripheral portion tapers toward theperipheral edge. In certain embodiments, the diameter of the peripheraledge is from about from about 12 mm to 16 mm, 13 mm to about 16 mm, fromabout 13.5 mm to about 15.5 mm, from about 14 mm to about 15 mm, and incertain embodiments, from about 14.2 mm to about 14.8 mm.

The peripheral portion is characterized by a lower rigidity than theinner portion and can be formed from a material having a lower modulusthan that of the inner portion. In certain embodiments, the materialforming the peripheral portion is characterized by a modulus from about0.5 MPa to about 2.0 MPa, from about 0.8 MPa to about 1.7 MPa, fromabout 1.0 MPa to about 1.4 MPa, and in certain embodiments, about 1.2MPa.

The peripheral portion is configured to provide tear flow between theanterior surface of the device and the epithelium. In certainembodiments, the peripheral portion comprises a plurality offenestrations extending from the anterior to the posterior surface ofthe peripheral portion. In certain embodiments, the plurality offenestrations are disposed at a radius from a central optical axis ofthe ophthalmic lens such as for example, at a radius proximate to theinterface between the inner portion and the peripheral portion. Theplurality of fenestrations may be symmetrically or asymmetricallydisposed. The fenestrations may be configured to pump tear liquidbetween the peripheral portion and the epithelium when the eye blinks soas to maintain a tear layer between the posterior surface of the lensand the epithelium and/or across the anterior surface of the lens. Incertain embodiments, the plurality of fenestrations may be configured tofacilitate removal of the lens from the eye. In certain embodiments, theplurality of fenestrations may be configured to facilitate airdissipation if air bubbles are trapped underneath the lens, In certainembodiments, the plurality of fenestrations facilitates the removal ofair bubble entrapped within any lenticular volumes following applicationof a lens to a patient's eye. The plurality of fenestrations mayfacilitate both removal of the lens form the eye and dissipation of airbubbles. In certain embodiments, the plurality of fenestrations improvesthe reproducibility of visual outcome in a population of patientswearing the lens compared to the visual outcome in a population ofpatients wearing a comparable lens without fenestrations.

In certain embodiments, the inner portion, the peripheral portion, orboth the inner and peripheral portions of an ophthalmic lens provided bythe present disclosure are radially symmetric. In certain embodiments,the anterior surface of the inner portion and the posterior surface ofthe inner portion are radially symmetric.

In certain embodiments of ophthalmic lenses provided by the presentdisclosure, the inner portion and the peripheral portion are configuredto allow movement of the lens relative to the eye in response toblinking of the eye. In such embodiments, an ophthalmic lens isconfigured such that the inner optical portion centers on the opticalportion of the cornea following blinking. During blinking the innerportion, the peripheral portion, or both the inner and peripheralportions may deform and/or move with respect to the center optical axisof the cornea. When an ophthalmic lens is worn by a patient, dependingat least in part by the shape of the patient's eye and the configurationof the lens, the ophthalmic lens may move during blinking or may exhibitonly micro-movement. However, in certain embodiments, a lens is notconfigured to resist movement such that, for example, the peripheraledge of the lens is not configured to fixedly engage the epithelium orsclera such that the inner portion resists movement relative the cornea.

In certain embodiments of ophthalmic lenses provided by the presentdisclosure, the inner portion and the peripheral portion are configuredto provide a tear fluid flow between the peripheral portion of theophthalmic lens and the epithelium.

The peripheral portion of a lens can be tapered toward the peripheraledge. The taper may be continuous or discontinuous. The peripheralportion may be flared outward toward the peripheral edge and is referredto as a modified heeled configuration. A cross-sectional profile of alens is determined by the inner portion characterized by a substantiallyconstant thickness and the shape of the taper of the peripheral portion.In general, the cross-sectional shape of an ophthalmic lens isconfigured to correct refractive error of any eye, center the lens onthe optical portion of the cornea, facilitate motion of the lens withrespect to the eye, provide flow of tear liquid between the posteriorsurface of the lens and epithelium, and to provide comfort to a patientwearing the lens. The ability of the lens to move, provide a fluidlayer, and exchange tear fluid facilitates eye health and improvescomfort for extended wear.

Ophthalmic lenses provided by the present disclosure include featuresintended to confer attributes of benefit to a person wearing the lens.For example, the semi-rigid inner optic portion provides a nearspherical anterior surface and maintains the intended near sphericalcurvature during wear. By minimizing toricity and irregularities of theanterior surface of the lens and minimizing flexure, the lens providesgood vision. Vision and health of the eye are enhanced by the presenceof fenestrations. Furthermore, the semi-rigid inner optic portion issufficiently flexible to accommodate a range of corneal curvatures andis able to mask corneal toricity by forming a lenticular tear volumebetween the posterior surface of the lens and the cornea. In certainembodiments, in part depending on the shape of a cornea, one or morelenticular volumes are formed between the posterior surface of the lensand the cornea.

The fenestrations provide a supply of fluid between the posteriorsurface of the lens and the epithelium of the eye to maintain a tearlayer, which supports the intended curvature of the lens to provide goodvision. Fenestrations also maintain eye health by allowing for rapidtear exchange to circulate metabolic waste and to transmit oxygen to thetear layer. Fenestrations also prevent a lens from creating vacuum sealto the eye, allowing the lens to move on the eye and facilitating lensremoval.

The materials forming the outer portions of the inner optic portion andthe outer peripheral portion can have a low Young's modulus thatimproves patient comfort. Also, a thickness of a material along theposterior surface of the inner optic portion having a Young's modulusless than the modulus of the material forming the inner optic portionmay provide additional comfort. In addition to the effect of thefenestrations, eye health is further enhanced by the use of siliconesand/or silicone hydrogels to form the lens. Silicones and/or siliconehydrogels are physiologically compatible and can provide high oxygenpermeability and ion permeability.

In certain embodiments, ophthalmic lenses provided by the presentdisclosure include a plurality of fenestrations. The fenestrations canprovide a supply of tear fluid to establish and maintain a tear volumebetween the posterior surface of the inner optic portion and the corneato support the intended lens curvature, allow exchange of tear fluid tocirculate metabolic waste, and to supply and maintain a high oxygencontent at the surface of the cornea.

Fenestrations can be disposed within the inner optic portion of theophthalmic lens, within the peripheral portion of the ophthalmic lens,or within both the inner optic and peripheral portions of the ophthalmiclens. In certain embodiments, the fenestrations may be disposed alongone or more rings situated at a radius from the central axis of theophthalmic lens. Each ring may include from one (1) to twenty (20)fenestrations. In certain embodiments, fenestrations may be disposedalong one or more rings disposed at different radii from the centralaxis of the ophthalmic lens.

For example, in certain embodiments the plurality of fenestrations canbe disposed at a combination of a first radius, a second radius, a thirdradius, and a fourth radius from a central optical axis of theophthalmic lens, wherein: the first radius is disposed within the inneroptic portion and from 0.5 mm to 1.0 mm from an interface between theinner optic portion and the peripheral portion; the second radius isdisposed within the peripheral portion and from 0.5 mm to 1.5 mm fromthe interface between the inner optic portion and the peripheralportion; the third radius is disposed within the peripheral portion andfrom 1.5 mm to 2.5 mm from the interface between the inner optic portionand the peripheral portion; and the fourth radius is disposed within theperipheral portion and from 0.5 mm to 2.5 mm from an edge of theperipheral portion.

In certain embodiments, an ophthalmic lens may comprise anywhere from 1to 20 fenestrations. The location and cross-section of certainfenestrations may be configured to pump tear liquid between theposterior surface of the lens and the epithelium when the eye blinks.Circulation of tear fluid can help to maintain eye health. Certainfenestrations may be configured to maintain a tear layer between the eyeand one or more portions of the posterior surface of the inner opticportion. The tear layer can help to maintain health of the eye, can helpto provide comfort, and can facilitate removal of the lens from the eye.Certain portions of an ophthalmic lens may conform to the cornea whileother portions may create one or more lenticular volumes between theposterior surface of a lens and the cornea. Certain fenestrations can beconfigured to maintain tear fluid within the lenticular volumes. Thelenticular volumes in conjunction with the ophthalmic lens form a tearlens for improving vision. Fenestrations located proximate to theinterface between the inner optic portion and the peripheral portion mayserve to maintain tear fluid within lenticular volumes. Certainfenestrations such as those located within the peripheral portion may beconfigured to maintain eye health and to facilitate removal of the lensfrom the eye.

In certain embodiments, a plurality of fenestrations is disposed withinthe inner optic portion to provide for sufficient tear flow beneath theinner optic portion to establish and maintain a lenticular tear volumebetween the posterior surface of the inner optic portion and the cornea.The tear volume maintains the spherical shape of the lens on the eye toimprove patient vision. While certain portions of the posterior surfaceof the lens can conform to the surface of the cornea, where the corneais characterized by toric and/or cylindrical irregularities, the inneroptic portion is sufficiently rigid that it bridges the cornealirregularities creating one or more lenticular volumes which are filledwith tear fluid.

The number and location of the fenestrations can be configured toachieve one or more of these benefits.

In certain embodiments, the tear volume beneath certain portions of theinner optic portion of the ophthalmic lens can be maintained byfenestrations located just outside the diameter of the inner opticportion of the lens.

Fenestrations located within the peripheral portion of the lens canmaintain eye health, provide tear film that facilitates motion of thelens on the cornea, and/or facilitate removal of the lens from the eye.

Fenestrations may be any suitable shape, be situated and any suitableorientation with respect to the cross-sectional profile of the lens. Incertain embodiments, fenestrations are characterized by a circularcross-section having a diameter from about 50 μm to about 300 μm, fromabout 80 μm to about 250 μm, and in certain embodiments, from about 100μm to about 200 μm.

In certain embodiments, ophthalmic lenses provided by the presentdisclosure include a sag height from about 3 mm to about 5 mm, incertain embodiments, from about 3.5 mm to about 4.5 mm, and in certainembodiments, from 3.5 mm to about 4.2 mm. The sag height refers to thedistance from the center of the lens to a line extending from theperipheral edge of a lens. For a particular optic curvature, lenses maybe provided with several different sag heights to accommodate differenteyeball sizes among a general population of patients. For example,lenses having particular optic curvature may be provided with threedifferent sag heights from a nominal sag height of 4.0 mm in steps fromabout 0.15 mm to 0.3 mm. For example, for lenses having a particularoptic curvature, lenses having sag heights of 3.7 mm, 4.0 mm, and 4.3 mmcan be provided. In certain embodiments, for lenses having a particularoptic curvature, lenses having sag heights of 3.85 mm, 4.0 mm, and 4.15mm; sag heights of 3.8 mm, 4.0 mm, and 4.2 mm; and in certainembodiments, sag heights of 3.75 mm, 4.0 mm, and 4.25 mm, can beprovided.

In certain embodiments, an ophthalmic lens for correcting a refractiveerror of an eye, the eye having a cornea with a refractive shapeextending across an optical region of the eye, comprises: an inner opticportion configured to be disposed over the optical region of the cornea;a posterior surface extending along the inner optic portion adjacent theeye when the inner portion is disposed over the optical region, theinner optic portion configured so that engagement of the posteriorsurface against the eye deforms the posterior surface and so that theposterior surface has a shape diverging from the refractive shape of thecornea; a peripheral portion of the ophthalmic lens disposed radiallyoutward of the inner optic portion; and an anterior surface of theophthalmic lens extending along the inner optic portion opposite theposterior surface configured to mitigate the refractive error; wherein,the inner optic portion is characterized by an inner rigidity and theperipheral portion is characterized by a peripheral rigidity; the innerrigidity is greater than the outer rigidity.

In certain embodiments of an ophthalmic lens, the inner optic portion ischaracterized by a substantially spherical profile.

In certain embodiments of an ophthalmic lens, the refractive error ofthe eye includes a cylindrical error; and the inner optic portion ischaracterized by a substantially spherical surface so that correction ofthe cylindrical error by the lens is primarily effected by thedivergence of the shape of the inner optic portion from the refractiveshape of the cornea.

In certain embodiments of an ophthalmic lens, the inner optic portionand the peripheral portion are configured to allow movement relative tothe eye.

In certain embodiments of an ophthalmic lens, the inner optic portionand the peripheral portion are configured to provide a tear fluid flowbetween the inner optic portion of the ophthalmic lens and the cornea.

In certain embodiments of an ophthalmic lens, the refractive error ofthe eye comprises astigmatism; and the anterior surface of the inneroptic portion and the posterior surface of the inner optic portion areradially symmetric.

In certain embodiments of an ophthalmic lens, the ophthalmic lensfurther comprises a plurality of fenestrations, wherein the plurality offenestrations is disposed within the inner optic portion, the peripheralportion, or both the inner optic portion and the peripheral portion.

In certain embodiments of an ophthalmic lens, at least some of theplurality of fenestrations are disposed proximate an interface betweenthe inner optic portion and the peripheral portion.

In certain embodiments of an ophthalmic lens, at least some of theplurality of fenestrations are configured to pump tear liquid betweenthe posterior surface of the lens and the epithelium when the eyeblinks.

In certain embodiments of an ophthalmic lens, at least some of theplurality of fenestrations are configured to maintain tear fluid withinone or more lenticular volumes between the posterior surface of theinner optic portion and the cornea.

In certain embodiments of an ophthalmic lens, the inner optic portion isprimarily configured to correct vision and the peripheral portion isprimarily configured to enhance comfort.

In certain embodiments of an ophthalmic lens, the posterior surface ofthe inner optic portion comprises a thickness of a low modulus material.

In certain embodiments of an ophthalmic lens, the ophthalmic lens ischaracterized by a sagittal height (SAG) from 3 mm to 5 mm.

In certain embodiments of an ophthalmic lens, the anterior surface ischaracterized by a spherical profile without a cylindrical component.

In certain embodiments of an ophthalmic lens, the ophthalmic lens isconfigured to center on the optical region of the cornea followingblinking of the eye.

In certain embodiments, methods for correcting a refractive error of aneye, the eye having a cornea with a refractive shape extending across anoptical region of the cornea, comprise: positioning an ophthalmic lenson the eye so that an inner optic portion of the ophthalmic lens isdisposed over the optical region of the cornea, wherein at least aportion of a posterior surface of the positioned ophthalmic lens extendsadjacent the eye and is deformed by the eye; and wherein a shape of theposterior surface diverges from the refractive shape of the cornea sothat the ophthalmic lens mitigates the refractive error.

In certain methods for correcting refractive error, the refractive errorof the eye comprises astigmatism, spherical defocus, or a combinationthereof; the ophthalmic lens further comprises a plurality offenestrations, wherein the plurality of fenestrations is disposed withinthe inner optic portion, the peripheral portion, or both the inner opticportion and the peripheral portion; the inner portion of the ophthalmiclens is deformable and a peripheral portion of the ophthalmic lensdisposed outward of the inner optic portion is characterized by arigidity lower than a rigidity of the inner portion; and mitigation ofthe refractive error when viewing with the eye through the anteriorsurface is substantially independent of the shape of the peripheralportion throughout a range of astigmatic errors of at least about 1.5 D,and is independent of a rotational orientation of the ophthalmic lensabout a viewing axis of the eye.

In embodiments in which the inner optic portion is configured to providea spherical correction, the thickness of the inner portion will not beuniform, and will be shaped to provide, for example, a spherical powerfrom about −3.00 D to about +3.00 D, and in certain embodiments, fromabout −10.00 D to about +10.00 D. In such embodiments, the thickness ofthe inner optic portion can taper from the center toward the peripheralportion depending on the spherical power.

In embodiments, in which correction of spherical power is not required,the thickness of the inner portion may be substantially uniform.

In certain embodiments, ophthalmic lenses are radially symmetric.

Certain embodiments of ophthalmic lenses provided by the presentdisclosure can be configured to provide one or more lenticular volumesbetween at least a portion of the posterior surface of the inner opticportion and the surface of the cornea.

When placed on the cornea, the posterior surface of the inner opticportion of the ophthalmic lens comprises a shape diverging from therefractive shape of the cornea and define a lenticular volume. Incertain embodiments, at least a portion of the peripheral portion mayalso diverge from the refractive shape of the cornea and may define alenticular volume. The peripheral portion of the lens may diverge fromthe refractive shape of the cornea near the interface of the inner opticportion and the peripheral portion. Depending upon the shape of thecornea, one or more lenticular volumes may be formed

A lenticular volume defined by the peripheral portion of a lens may befluidly connected to a lenticular volume defined by the inner portionand may facilitate exchange of tear fluid within one or more lenticularvolumes. Tear exchange within a lenticular volume and to and from alenticular volume may be facilitated by fenestrations through theophthalmic lens. Such fenestrations may serve to pump tear fluid to andfrom a lenticular volume during blinking of the eye.

In certain embodiments, the inner optic portion comprises a shapeconfigured to provide a spherical power to correct refractive error, andin certain embodiments, comprises a shape configured to correctnon-spherical refractive error.

In certain embodiments, the anterior surface of the inner optic portionis characterized by a substantially spherical shape.

In certain embodiments, the posterior surface of the inner optic portionmay be characterized by a substantially spherical shape.

In other embodiments, the posterior surface of the inner optic portionmay be characterized by a non-spherical shape such as, for example, atoric shape. In embodiments in which the posterior surface ischaracterized by a toric shape, the shape can be configured such thatthe toric shape of inner optic portion aligns with an astigmatic axis ofthe cornea. The toric shape can be from 0.75 D to 1.25 D. The toricshape can reduce the lenticular volume compared to a spherical shape.The reduced lenticular volume results in less lens flexure of thecontact lens during blinking. The tonic shape of the posterior surfacecan induce a certain amount of astigmatism.

The induced astigmatism by the toric shape of the posterior surface canbe compensated by having an anterior surface with a toric shape. Theamount of toricity of the posterior surface may be sufficient to correctany astigmatism induced by the toricity of the anterior surface of thelens. The anterior surface may also include a shape for sphericalcorrection.

In certain embodiments, an ophthalmic lens will have a spherical powereffect bitoric design that is independent of lens orientation.

In certain embodiments, the inner optic portion comprises a singlematerial throughout the thickness.

In certain embodiments, the inner optic portion comprises more than onematerial, with different materials disposed in different axial portionsof the inner optic portion. For example, the inner optic portion maycomprise a first portion disposed toward and/or forming the anteriorsurface of the inner optic portion, toward and/or forming the posteriorsurface of the inner optic portion, or toward the center of the inneroptic portion. In such embodiments, the first portion comprises amaterial characterized by a modulus higher than that of a materialforming the peripheral portion. The first portion comprises a materialand is characterized by a thickness sufficient to provide correction ofrefractive error.

By virtue of being characterized by at least different moduli, thematerial forming the first portion is not structurally the same as theanterior material and/or the posterior material, although the materialsmay be based on similar chemistries and/or materials. In certainembodiments, the anterior material can be the same as the posteriormaterial and in certain embodiments the anterior material can bedifferent than the posterior material. In certain embodiments, theanterior material, the posterior material, and the peripheral materialare the same and the anterior material and the posterior material extendfrom the inner optic portion to the peripheral portion.

In certain embodiments, one or more surfaces of the first portion may betreated to enhance the mechanical integrity and/or adhesion of theinterface with the first portion and the anterior portion and/or theposterior portion.

In certain embodiments, the inner optic portion, the peripheral portion,or both the inner optic portion and the peripheral portion may compriseone or more coatings on the anterior surface, the posterior surface, orboth the anterior surface and the posterior surface.

The one or more coatings may be selected, for example, to improvecomfort, to facilitate tear flow, and/or to modify thehydrophilicity/hydrophobicity of the lens or portion of the lens. Theone or more coatings may be the same in both the inner optic portion andin the peripheral portion or may be different in different portions ofthe lens.

In certain embodiments, the materials forming the inner optic portion,the peripheral portion, or both the inner optic portion and theperipheral portion are non-hydrous. A non-hydrous material refers to amaterial characterized by a water content less than about 10 wt %, lessthan about 5 wt %, and in certain embodiments, less than about 1 wt % inits fully hydrated state.

A material may be intrinsically non-hydrous or may be renderedfunctionally non-hydrous by situating or encapsulating a materialbetween non-hydrous materials and/or by a coating with a non-hydrousand/or hydrophobic material. For example, a hydrophobic coating such asa hydrocarbon or fluorocarbon coating may be used to prevent hydrationof a hydrous material.

The material forming the inner optic portion and the peripheral portionmay be characterized by the same or by a different water content.

In embodiments in which the inner optic portion comprises more than oneaxial portion, the first or optical portion may comprise a non-hydrousmaterial and the anterior portion and/or posterior portions may comprisea hydrous material, such as a hydrogel.

The inner optic portion comprises an inner material characterized by aninner modulus, and the peripheral portion comprises a peripheralmaterial characterized by a peripheral modulus, wherein the innermodulus is greater than the outer modulus.

The materials forming the inner optic portion and the peripheral portionmay be polymers, copolymers, homopolymers, graft polymers, or graftcopolymers. The materials may comprise a combination of more than onedifferent type of materials. In certain embodiments, the materials maybe hydrogels. A hydrogel refers to a cross-linked polymeric material,which is not water-soluble and contains at least 10 wt % water withinthe polymer matrix when fully hydrated. In certain embodiments, amaterial forming the inner optic portion and/or the peripheral portionis not a hydrogel and contains less than 10 wt % water.

Examples of suitable materials for forming the inner optic portioninclude, for example, silicones, fluorosilicones, polyurethanes,polyether block amides, polycarbonates, polymethyl methacrylates,polystyrenes, and acrylonitrile butadiene styrene, polymers ofmethacrylate and acrylate esters of various alcohols, includingaliphatic, aromatic, siloxane-containing, fluorocarbon-containingalcohols, and combinations of any of the foregoing. Such materials forthe inner optic portion are characterized by a modulus from about 100MPa to about 3000 MPa.

Examples of suitable materials for forming the peripheral portioninclude, for example, silicone, silicone hydrogels, and hydrogels ofoptically clear materials such as those listed for the inner portionmodified with a suitable hydrophilic material such aspolyhydroxyethylmethacrylate hydrogels, polyvinylpyrrolidone hydrogels,polyvinylalcohol hydrogels, silicone hydrogels.

Ophthalmic lenses provided by the present disclosure may be manufacturedusing any suitable contact lens manufacturing technology including, forexample, cast molding, injection molding, insert molding, transfermolding, thermoforming, vacuum forming, or a combination of any of theforegoing.

In certain embodiments, the inner optic portion comprising a highermodulus material may be thermoplastic and can be fabricated by injectionmolding. The inner optic portion may then be inserted into a mold cavityand the peripheral portion formed to retain the inner optic portion.This may be accomplished, for example, using insert molding or castmolding technologies. In certain embodiments, the material forming theperipheral portion also covers the anterior surface, the posteriorsurface, or both the anterior surface and the posterior surface of theinner portion. Cast molding resins may be, for example, heat cured orradiation cured such as UV cured.

Scaffolds provided by the present disclosure may be fabricated using anysuitable technology. The technology may be selected as appropriate forthe material or materials used to form the scaffold.

For example, scaffolds may be fabricated using injection molding,compression molding, thermoforming, a lathe, or cast molding.

The material forming the scaffold may be a thermoplastic or may be acurable liquid. A curable material may be curable by heat or byradiation.

The openings in the scaffold may be formed at the time the scaffold isfabricated or may be machined after the scaffold is formed. The openingsmay be incorporated into the mold design. The openings may also bemachined after the part is formed using, for example, laser machining,die cutting, or other suitable method.

To fabricate a contact lens, the scaffold may be first positioned in amold cavity and then a second material formed around the scaffold byinjection molding, compression molding, cast molding or other suitablemolding technology. The second material can form the anterior andposterior surface of the inner optic portion, fill the openings in thescaffold, and also form the peripheral portion of the contact lens.

In certain embodiments the low modulus material may be a thermoplasticand the contact lens formed by insert molding the scaffold.

For high volume manufacturing it may be desirable to position thescaffold in a cast mold, fill the mold with a liquid low modulusmaterial, and cure the low modulus material using actinic radiation suchas ultraviolet radiation.

While certain embodiments have been described in some detail, by way ofexample and for clarity of understanding, those of skill in the art willrecognize that a variety of modifications, adaptations, and changes maybe employed. Hence, the scope of the present invention should be limitedsolely by the appended claims.

What is claimed is:
 1. An ophthalmic lens for correcting a refractiveerror of an eye, wherein the eye comprises a cornea, and the ophthalmiclens comprises: an inner optic portion configured to be disposed over anoptical region of the cornea, wherein the inner optic portion comprises:an inner material; and a scaffold embedded within the inner material,wherein the scaffold comprises one or more openings; and a peripheralportion disposed radially outward of the inner optic portion.
 2. Theophthalmic lens of claim 1, wherein, when applied to the eye, the inneroptic portion comprises a posterior surface characterized by a shapediverging from a refractive shape of the cornea.
 3. The ophthalmic lensof claim 1, wherein, the inner material is characterized by an innermaterial modulus; the scaffold comprises a scaffold materialcharacterized by a scaffold modulus; and the scaffold modulus is greaterthan the inner material modulus.
 4. The ophthalmic lens of claim 3,wherein the scaffold modulus is within a range from 300 MPa to 3000 MPa.5. The ophthalmic lens of claim 3, wherein the inner material modulus iswithin a range from 0.1 MPa to 10 MPa.
 6. The ophthalmic lens of claim1, wherein the scaffold is characterized by a substantially uniformthickness.
 7. The ophthalmic lens of claim 1, wherein the scaffold ischaracterized by a substantially uniform thickness ranging from 50 μm to500 μm.
 8. The ophthalmic lens of claim 1, wherein the scaffoldrepresents from 20 vol % to 80 vol % of the volume of the inner opticportion.
 9. The ophthalmic lens of claim 1, wherein the inner opticportion is characterized by a maximum thickness from 50 μm to 500 μm.10. The ophthalmic lens of claim 1, wherein the inner optic portion ischaracterized by a rigidity from 1E9 MPa-μm³ to 1E11 MPa-μm³.
 11. Theophthalmic lens of claim 1, wherein the inner optic portion ischaracterized by an oxygen transmissibility of at least 80 Dk/t.
 12. Theophthalmic lens of claim 1, wherein the inner optic portion comprises ananterior surface and a posterior surface wherein each of the anteriorsurface and the posterior surface is characterized by a sphericalprofile.
 13. The ophthalmic lens of claim 1, further comprising aplurality of fenestrations, wherein the plurality of fenestrations isdisposed within the inner optic portion, within the peripheral portion,or within both the inner optic portion and the peripheral portion. 14.The ophthalmic lens of claim 1, wherein, the refractive error of the eyecomprises astigmatism; and each of an anterior surface of the inneroptic portion and a posterior surface of the inner optic portion isradially symmetric.
 15. The ophthalmic lens of claim 1, wherein the oneor more openings are filled with the inner material.
 16. An ophthalmiclens for correcting a refractive error of an eye, wherein the eyecomprises a cornea, and the ophthalmic lens comprises: an inner opticportion configured to be disposed over an optical region of the cornea,wherein the inner optic portion comprises: an inner material; and ascaffold embedded within the inner material; and a peripheral portiondisposed radially outward of the inner optic portion; wherein each ofthe inner material and the scaffold material comprise similar materialchemistries.
 17. An ophthalmic lens for correcting a refractive error ofan eye, wherein the eye comprises a cornea, and the ophthalmic lenscomprises: an inner optic portion configured to be disposed over anoptical region of the cornea, wherein the inner optic portion comprises:an inner material; and a scaffold embedded within the inner material;and a peripheral portion disposed radially outward of the inner opticportion; wherein each of the inner material and the scaffold materialcomprises a hydrogel.
 18. An ophthalmic lens for correcting a refractiveerror of an eye, wherein the eye comprises a cornea, and the ophthalmiclens comprises: an inner optic portion configured to be disposed over anoptical region of the cornea, wherein the inner optic portion comprises:an inner material; and a scaffold embedded within the inner material;and a peripheral portion disposed radially outward of the inner opticportion; wherein each of the inner material and the scaffold material ischaracterized by substantially the same refractive index within +/−0.02.19. An ophthalmic lens for correcting a refractive error of an eye,wherein the eye comprises a cornea, and the ophthalmic lens comprises:an inner optic portion configured to be disposed over an optical regionof the cornea, wherein the inner optic portion comprises: an innermaterial; and a scaffold embedded within the inner material; and aperipheral portion disposed radially outward of the inner optic portion;wherein the inner optic portion is configured to maintain one or morelenticular volumes between a posterior surface of the inner opticportion and the optical region of the cornea.
 20. An ophthalmic lens forcorrecting a refractive error of an eye, wherein the eye comprises acornea, and the ophthalmic lens comprises: an inner optic portionconfigured to be disposed over an optical region of the cornea, whereinthe inner optic portion comprises: an inner material; and a scaffoldembedded within the inner material, wherein the scaffold comprises ascaffold material; and a peripheral portion disposed radially outward ofthe inner optic portion; wherein the inner material and the scaffoldmaterial exhibit similar swelling when hydrated.